Page History

The Medical History (MH) is an Events domain is used to represent information collected about medical conditions that started prior to the start of the study. The study timepoint at which events stop being pre-study events (medical history)   is determined by the sponsor applicant according to the requirements of the study. However, the "stop" timepoint may be no earlier than the date of informed consent (which is recorded for each subject in the RFICDTC variable in the Demographics (DM) domain) and no later than the start date of the Study Reference Period study reference period (which is recorded for each subject in the RFSTDTC variable in the DM dataset).   The timepoint is usually identifiable as the point at which medical history information is collected; medical conditions starting after the collection of medical history information are often considered to be on-study events. Note that the : The relative timing variables used to represent medical history events as being "prior" or "ongoing" will depend on whether the collection of medical history information coincides with the start of the study reference period.